DEN250015
- 510(k) number
- DEN250015
- Device name
- Neurolyser XR (NXR100)
- Applicant
- Fusmobile, Inc. GA · US
- Product code
- SGN — High Intensity Focused Ultrasound System For Periphe
- Decision date
- 2025-11-14
- Date received
- 2025-04-25
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN250015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.